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TECHNOLAS 217A EXCIMER LASER SYSTEM

FDA premarket approval P990027/S004 · decided 2003-02-25

Approval details

PMA number
P990027
Supplement
S004
Supplement type
Panel Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Trade name
TECHNOLAS 217A EXCIMER LASER SYSTEM
Generic name
Excimer laser system
Applicant
Technolas Perfect Vision GmbH
Date received
2001-12-14
Decision date
2003-02-25
Days to decision
438 days
Decision code
APPR
Product code
LZS
Advisory committee
Ophthalmic
Expedited review
No
Location
München
Statement
APPROVAL FOR THE TECHNOLAS 217A EXCIMER LASER SYSTEM. THE DEVICE USES AN OPTICAL ZONE TREATMENT RANGE FROM 5.00 MM TO 6.00 MM WITH A BLEND ZONE OF 1.90 MM FOR SPHERICAL HYPEROPIA AND 1.75 MM FOR HYPEROPIC ASTIGMATISM. THE LASER IS LOCKED OUT FOR REFRACTIVE CORRECTIONS GREATER THAN +4.00 D SPHERE AND GREATER THAN +2.00 D CYLINDER. THE DEVICE IS INDICATED FOR LASER IN-SITU KERATOMILEUSIS (LASIK) TREATMENTS: 1) FOR THE REDUCTION OR ELIMINATION OF LOW-TO-MODERATE NATURALLY OCCURRING HYPEROPIA UP TO

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